FDA.reportPublic FDA data

I-MED Non-Contact Infrared digital Clinical Thermometer

Primary DI
00622554057004
Brand
I-MED Non-Contact Infrared digital Clinical Thermometer
Company
I-Med Pharma Inc
Model
5700
Catalog number
5700
Device description
Ideal for quickly detecting elevated body temperature using a non-contact design. Measures body temperature from 90°F to 109°F (32.0°C to 42.5°C) without contact. Accurate to 0.5°F (0.3°C) with 0.1°F/°C resolution. Adjustable alarm alerts user visually and audibly when temperature exceeds programmed limit. Optimum measurement distance of 2 in. to 5.9-in. (5 to 15 cm).
Published
2020-06-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FLLThermometer, electronic, clinical
FQZTHERMOMETER, CLINICAL COLOR CHANGE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2
FQZThermometer, Clinical Color ChangeGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00622554057004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00622554057004006225540570046225540570040622554057004

GMDN Terms#

Term, Definition table
TermDefinition
Infrared patient thermometer, skinA hand-held, electrically-powered instrument designed to estimate the temperature of a site on the skin (e.g., axilla, forehead) by measurement of body infrared emissions at this particular point. It provides a method to determine temperature patterns or variations on the surface of the skin (e.g., due to differences in perfusion). This device may be used in the home. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(514)758-9998ilan@imedpharma.com

Regulatory Flags#

DUNS number
249008772
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00622554008907I-RELIEF Hot and Cold Therapy Eye Mask089008902020-06-18
00622554050005I-MED Nitrile Powder-Free and Latex-Free Gloves500050002020-06-18
00622554051002I-MED Surgical Mask510051002020-06-18
00622554052009I-MED KN95 Respirator Mask520052002020-06-18
00622554053006I-MED Single Use Face Mask530053002020-06-18
00622554054003I-MED Protective Facshield540054002020-07-07
00622554055000I-MED Protective Isolation Gown550055002020-06-18
00622554050012I-MED Nitrile Powder-Free and Latex-Free Gloves500050002020-06-18
00622554055017I-MED Surgical Mask510051002020-06-18
00622554052016I-MED KN95 Respirator Mask520052002020-06-18
00622554051019I-MED Protective Isolation Gown550055002020-06-18
00622554054010I-MED Protective Facshield540054002020-07-07

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Primary DI, Brand, Company table
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08698870325211FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22